Quality Assurance Continuous Improvement

LOUISE MARSALIS

Mayfield Village, OH *****

480-***-**** - ad5ruo@r.postjobfree.com

PROFESSIONAL SUMMARY

Thorough Quality Professional adept at creating a quality culture and providing leadership in GMP regulated environments. Hardworking and meticulous with a passion for continuous improvement.

SKILLS

Expertise in Quality Management

Systems

Engineering Change Management

Lean Manufacturing Principles

Measurement System Analysis

First Article Inspection

Supplier Quality Management

Statistical Process Control

Failure Modes and Effects Analysis

Process Mapping

Documentation and Reporting

Attention to Detail

Failure Investigation and Analysis

Lean Six Sigma

Quality Assurance

Quality Documentation Management

Continuous Improvement Initiatives

Customer Complaint Handling

Root Cause Analysis

WORK HISTORY

12/2021 to Current Sr. Quality Engineer

Centerline Biomedical – Cleveland, OH

Responsible for Document Control and Maintaining the QMS. Authors, collaborates, and approves Quality System documents that include Change Controls, DHF, DMR, DHR, labels and product specifications. Performs internal audits and supplier audits.

Collect data and present data for Management Review Lead for CAPA and NCR investigations.

Contributed to root cause analysis to determine core reason for failures and errors. Performed quality inspections and drafted reports to detail non-conforming material issues.

12/2016 to 12/2021 Manufacturer Quality Assurance

Xellia Pharmaceuticals

• Initiate Global Change Control for Raw Materials Specification

• Ensure that Quality Assurance personnel performing incoming inspection are trained on the relevant QA standard operation procedures.

• Review of inspection data and results in relation to release of specified materials in Xellia CLE.

• Support retention program for Xellia marketed products.

• Support Annual Product Report as it pertains to Specifications, Materials release, and retention program.

• Oversee Retention Program for Active Pharmaceutical Ingredients (API), Final Dosage Form (FDF), and Contract Manufacturing Organization (CMO) requirements.

• Collecting of data for Quality Monthly Report; Retention Program, Released Materials, Rejected Materials, SCAR, etc.

• Responsible for review and approval of Commissioning Protocol for Non-Viable and Viable Particulate Monitoring System, Filling Line, and Capper Line.

• Make recommendations on URS, FDS, IOQ, and QC document format and content.

• QA representative for Validation Teams for Facilities, Filling, Lyophilization, and Compounding.

06/2015 to 08/2016 Process Quality Engineer

Philips Healthcare

• Responsible for Calibration and PM of equipment used in manufacturing.

• Third Party Calibration House coordinator for management of tools.

• Trained Personnel on Calibration and PM procedures.

• Issued Non-Conformance and OOT reports to equipment owners.

• Review and Approve equipment calibration release reports.

• Provide statistical data on equipment calibration and OOT reports for Management Review Board.

• Organize documentation of equipment records for remediation project for Calibration/PM program.

• Revised procedures to comply with ISO and FDA requirements. 08/2014 to 12/2014 Sr. Quality Manager

Flambeau Inc.

• Created Specifications with Customer for medical device manufacturing

• Created the risk management program for medical device

• Created the FMEA documents used for device review

• Set up environmental monitoring program for Class 7 cleanroom

• Created SOP for Complaints, Risk Management, Validation Program, Trending, CAPA, and Management Review

03/2012 to 07/2014 Quality Manager

West Pharmaceutical

Responsible for creating and using Quality System processes to assure the quality specifications are met in all phases of design transfer, manufacturing of medical devices, complaint handling, and global distribution of medical products 10/2006 to 03/2012 Quality Engineer III

West Pharmaceutical

Provided leadership to ensure the preparation of quality plans and documentation adhere to international and FDA regulations

07/2004 to 10/2006 Quality Assurance Quality Control Manager Matrixx Initiatives Inc.

Directly responsible for all Quality Assurance and Quality Control decisions and for FDA compliance issues with all contracting laboratories and manufacturers

(10-15)

06/2002 to 05/2003 Senior Quality Specialist

Biovest International

Created and administered the Corrective Action and Preventative Action Program 09/2000 to 06/2002 Research Analyst Auditor

Massachusetts Department of Public Health

Responsible for collecting immunization data from health care providers throughout the state and submitting data to the CDC 06/1997 to 09/2000 Quality Assurance Compliance Specialists UMass Medical School

Responsible for quality compliance with FDA, Good Laboratory Practices and ICH guidelines

03/1995 to 06/1997 Quality Assurance Technical Support Specialists Copley Pharmaceuticals, Inc

10/1993 to 03/1995 Quality Assurance Specialists

Springborn Laboratories, Inc

EDUCATION

06/2002 MS: Health Services Administration

The University of Massachusetts at Lowell

06/1993 BS: Chemistry and Biology

Springfield College

ACCOMPLISHMENTS

Create Incoming Inspection program for Xellia CLE location. Contributed to the success of Qualifying Clean Utilities (WFI, Clean Steam, and Nitrogen) for use in facility, met deadline.

Hire and train in-process inspection, in-coming receiving inspection, metrology, and finished product QA Auditors.

QE for new product development team, write production, test protocols, inspection plans, validation protocols (IQ, OQ, PQ), supplier agreements, negotiate with customers on product specifications, and customer QA agreements. Created QMS for complaint program to track, trend, and log complaints. Wrote test method protocols to facilitate complaint investigation and report writing. Leaned out process to meet customer expectations and reporting requirement deadlines per FDA.

Six Sigma Black Belt project was to design and create QMS to handle the testing, release, and distribution of sterile product. Lean out the release testing requirements.

Lean out the process flow and handling of the product. Results of project reduced handling costs and resources required for release of product. Appointed to the companies Lean Leader program to contribute to cost reduction, resource allocation, and safety teams. Company goals were met. Work with Japan, German, Belgium, and Israel suppliers on quality testing requirements with regards to in-coming inspection of supplied components. Worked with supplier to resolve quality issues and to reduce waste of product due to testing at in-coming.

Lead for several FDA, ISO-13485, ISO-9001, Red Cross audit. Conducted supplier audits and due diligence audits. Worked with Corporate QA on global initiatives for quality assurance to harmonize product testing and customer expectations for product no matter where product was manufactured or distributed from.

MRB coordinator responsible for investigation into non-conforming product and CAPA. Write reports to customer and complete closure of reports and investigation per quality agreement with customer.

Train new employees on cGMP requirements. Conduct cGMP training annually to all employees.

Participated in and wrote Design Verification, Design Review, and Design Transfer documents.

COURSEWORK

Six Sigma Black Belt - October 2012

PDA Training class for Visual inspection of Filled Drug Product Effective Complaint Handling- Medical Device Reporting and Recalls Stability Program for Pharmaceuticals

Certified Quality Auditor

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